ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting

NCT04639856 | Completed DMC

• 1 other identifier: AFIC-IERB-SOP-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications, such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently performed with cardiopulmonary bypass (CPB) with cardiac arrest. Cardiopulmonary bypass leads to a systemic inflammatory response, which may be induced by the contact of circulating blood with artificial surfaces of the extracorporeal circuit.\[1\] To reduce postoperative complications caused by systemic inflammation, off-pump CABG was reintroduced into clinical practice in the early 1990s. During off-pump surgery, the coronary artery grafts are placed on coronaries of a beating heart, thereby avoiding aortic cross clamping and CPB. \[1\] There are many studies and debates about the two approaches to cardiac revascularization via CABG. This study aims to answer the question as to difference in the ICU stay of patients with low ejection fraction undergoing cardiac revascularization bet ween off pump and on pump coronary artery bypass grafting and better treatment option shall be adopted in future.

Conditions

Cardiac Revascularization

Keywords

Coronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

• ICU Stay

  post operative ICU stay in patients undergoing cardiac revascularization

  6 Months

Study Arms (2)

on-pump CABG

ACTIVE COMPARATOR

CABG using Cardiopulmonary Bypass Machine

Procedure: Coronary Artery Bypass Grafting

off-pump CABG

ACTIVE COMPARATOR

CABG without Cardiopulmonary Bypass Machine

Procedure: Coronary Artery Bypass Grafting

Interventions

Coronary Artery Bypass Grafting PROCEDURE

on-pump vs off pump Coronary artery Bypass Grafting

off-pump CABG; on-pump CABG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients of either gender between the ages of 40 to 80
• Ejection fraction of less than or equal to 35% undergoing CABG.
• undergoing CABG.

You may not qualify if:

• Patients with ejection fraction of more than 35%
• Patients with previous history of cardiac revascularization
• Patients with previous history of chronic kidney disease and obstructive sleep apnea.

Sponsors & Collaborators

• Armed Forces Institute of Cardiology, Pakistan: lead

Study Sites (1)

Armed Forces Institute of Cardiology, Rawalpindi

Rawalpindi, 44000, Pakistan

Location

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Surgeon

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: July 15, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)